South Africa is making a bold move to locally produce lenacapavir, a groundbreaking twice-yearly HIV prevention injection developed by Gilead Sciences, with support from Unitaid and United States Pharmacopeia (USP), a step that could transform access, strengthen Africa’s pharmaceutical independence, and accelerate the fight to end HIV on the continent by bringing production closer to those ...
On Monday, 9 March, Quamed’s Director, Ed Vreeke, had the opportunity to present Quamed’s activities to the Director-General of the African Medicines Agency, H.E. Dr. Delese Mimi Darko and her team. During the meeting, we discussed Quamed’s ongoing regulatory system capacity building and support to several African countries, including French-speaking NRAs, our GMP and GSDP ...
During a visit to Goma, Democratic Republic of Congo, QUAMED’s Executive Director had the opportunity to visit the warehouses of Asrames asbl. As recalled by its Director, Gaston Nyamambichi, the organization has been a member of QUAMED since the very beginning of the network. ASRAMES began working on the concept of access to quality medicines already in ...
Quamed’s Director had the pleasure of supporting the EAC Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (RCE-VIHSCM) in the mid-term review of its Strategic Plan (2020–2029). As part of the process, a three-day multi-stakeholder consultative meeting (2–4 March 2026) brought together experts from EAC Partner States. The depth of expertise in the room made the discussions ...
Millions still lack access to life-saving medicines, not because science failed, but because patents, prices, and politics get in the way. This deep dive unpacks how countries have used (and sometimes avoided) TRIPS flexibilities over the past 25 years to break monopolies, enable generics, and respond to crises from HIV to COVID-19 and cancer. With ...
A recent chapter titled “The Current Situation of Medicines Quality in Low- and Middle-Income Countries: New Challenges to be Addressed” (IntechOpen, 2025) sheds light on a growing global health concern: 10.5% of medicines worldwide are of poor quality, with the greatest impact seen in low- and middle-income countries. Harsh climates, weak regulatory systems, and fragmented supply ...
Ethiopia has reached a major milestone in medicines regulation, achieving WHO Maturity Level 3 (ML3)! This recognition highlights the Ethiopian Food and Drug Authority’s commitment to ensuring that medicines and vaccines meet international standards of quality, safety, and efficacy. Ethiopia now joins eight other African countries in demonstrating strong, well-functioning regulatory systems that protect public ...
The following message is courtesy of Dr Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium. Dear Friends, On 14 May, the WHO released the document “WHO guideline on balanced national controlled medicines policies to ensure medical access and safety: rapid communication” – accessible at https://iris.who.int/bitstream/handle/10665/381452/B09419-eng.pdf?sequence=1 The purpose is ‘to assist WHO Member States ...
A new study highlights the challenges of accessing essential medicines in the South Pacific, with lower-middle-income countries facing the lowest availability (59.1% public, 57.4% private) and significant affordability barriers. While upper-middle and high-income countries show better access, medicine prices remain high across the region. Urgent policy reforms and strategic initiatives are needed to address these ...
New Insights on the WHO-Listed Authority (WLA) Framework! The WHO has introduced an evidence-based, transparent framework to strengthen regulatory reliance and improve access to quality-assured medical products worldwide. The study highlights the WLA framework’s role in promoting regulatory standards across diverse regions, supporting the Sustainable Development Goals for global health. By enhancing collaboration between regulatory authorities, ...
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